Subjects were treated at either acute presentation of Lyme disease symptoms, following laboratory confirmation of symptoms, or following laboratory confirmation of asymptomatic infection. Active surveillance and prompt treatment of identified cases may have accounted for the low incidence of late Lyme disease manifestations. A similar proportion of definite Lyme disease cases in both vaccine and placebo groups were confirmed by positive culture, PCR analysis, or Western blot seroconversion.

Immunogenicity in Persons 15 to 70 Years of Age: In the pivotal efficacy trial, immunogenicity of LYMErix [Lyme Disease Vaccine (Recombinant OspA)] was assessed by measuring IgG anti-OspA antibodies and LA-2 equivalent antibodies in a subset of subjects 15 to 70 years of age enrolled at one study center. Table 1 shows the seropositivity rates and geometric mean titers (GMTs) following the second and third doses of LYMErix.

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